International Practices of Organ Donation


WHO Guiding Principles on Human Cell, Tissue & Organ Transplantation


1. Cells, tissues, and organs may be removed from the bodies of deceased persons for the purpose of transplantation if: any consent required by law is obtained, and there is no reason to believe that the deceased person objected to such removal.

 

2. Physicians determining that a potential donor has died should not be directly involved in cell, tissue, or organ removal from the donor or subsequent transplantation procedures; nor should they be responsible for the care of any intended recipient of such cells, tissues, and organs.

 

3. Donation from deceased persons should be developed to its maximum therapeutic potential, but adult living persons may donate organs as permitted by domestic regulations. In general, living donors should be genetically, legally, or emotionally related to their recipients. Live donations are acceptable when the donor's informed and voluntary consent is obtained, when professional care of donors is ensured and follow-up is well organized, and when selection criteria for donors are scrupulously applied and monitored. Live donors should be informed of the probable risks, benefits, and consequences of donation in a complete and understandable fashion; they should be legally competent and capable of weighing the information; and they should be acting willingly, free of any undue influence or coercion.

 

4. No cells, tissues, or organs should be removed from the body of a living minor for the purpose of transplantation other than narrow exceptions allowed under national law.

 

Specific measures should be in place to protect the minor and, wherever possible, the minor's assent should be obtained before donation. What is applicable to minors also applies to any legally incompetent person.

 

5. Cells, tissues, and organs should only be donated freely, without any monetary payment or other reward of monetary value. Purchasing, or offering to purchase, cells, tissues, or organs for transplantation, or their sale by living persons or by the next of kin for deceased persons, should be banned. The prohibition on sale or purchase of cells, tissues, and organs does not preclude reimbursing reasonable and verifiable expenses incurred by the donor, including loss of income, or paying the costs of recovering, processing, preserving, and supplying human cells, tissues, or organs for transplantation.

 

6. Promotion of altruistic donation of human cells, tissues, or organs by means of advertisement or public appeal may be undertaken in accordance with domestic regulation. Advertising the need for or availability of cells, tissues, or organs, with a view to offering or seeking payment to individuals for their cells, tissues, or organs, or, to the next of kin, where the individual is deceased, should be prohibited. Brokering that involves payment to such individuals or to third parties should also be prohibited.

 

7. Physicians and other health professionals should not engage in transplantation procedures, and health insurers and other payers should not cover such procedures, if the cells, tissues, or organs concerned have been obtained through exploitation or coercion of, or payment to, the donor or the next of kin of a deceased donor.

 

8. All health-care facilities and professionals involved in cell, tissue, or organ procurement and transplantation procedures should be prohibited from receiving any payment that exceeds the justifiable fee for the services rendered.

 

9. The allocation of organs, cells, and tissues should be guided by clinical criteria and ethical norms, not financial or other considerations. Allocation rules, defined by appropriately constituted committees, should be equitable, externally justified, and transparent.

 

10. High-quality, safe, and efficacious procedures are essential for donors and recipients alike. The long-term outcomes of cell, tissue, and organ donation and transplantation should be assessed for the living donor and the recipient in order to document benefit and harm. The level of safety, efficacy, and quality of human cells, tissues, and organs for transplantation, as health products of an exceptional nature, must be maintained and optimized on an ongoing basis. This requires implementation of quality systems including traceability and vigilance, with adverse events and reactions reported, both nationally and for exported human products.

 

11. The organization and execution of donation and transplantation activities, and their clinical results, must be transparent and open to scrutiny, while ensuring that the personal anonymity and privacy of donors and recipients are always protected.